INMETRO released new draft portaria for medical devices

INMETRO has released a draft of the new Portaria for Medical Devices which will replace Portaria 350/2010. This draft, published as portaria 407 on 26 of August 2014, is expected to be approved in the coming year and Portaria 350/2010 will be definitely cancelled as per 31 December 2018.

The draft Portaria 407 is now open for comments or input until 24 September 2014. If you have any feedback, you can send it to us or directly to INMETRO:

Instituto Nacional de Metrologia, Qualidade e Tecnologia – INMETRO
Diretoria de Avaliação da Conformidade - Dconf
Divisão de Regulamentação Técnica e Programas de Avaliação da Conformidade – Dipac
Rua da Estrela n.º 67 - 2º andar – Rio Comprido
CEP 20.251-900 – Rio de Janeiro – RJ, ou
E-mail: dipac.consultapublica@inmetro.gov.br

After the closing date, INMETRO will analize all comments and will publish the final version. Please have a look at the draft Portaria 407 here: Draft Portaria 407.pdf.

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